Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203385
Company: EUGIA PHARMA

Products on ANDA 203385

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2017	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203385

DACTINOMYCIN

INJECTABLE;INJECTION; 0.5MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203385	EUGIA PHARMA
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207232	HISUN PHARM HANGZHOU
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	213463	MEITHEAL
DACTINOMYCIN	DACTINOMYCIN	0.5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203999	XGEN PHARMS